BioData World Congress USA, Sept 14-15 in Boston

BioData Congress Americas 2016

BioData World Congress USA 2016
September 14-15, 2016

Hyatt Regency, Boston, MA

BioData World Congress USA is the world’s leading event for individuals working with Big Data in precision medicine.

The two day conference will feature case study applications of Big Data and Genomics to drive precision medicine into the clinic through the assembly of the multidisciplinary cohort involved in the delivery of the Precision Medicine

The event will cover a range of different topics including:

  • How to manage data generated in bioinformatics
  • How to utilise NGS to develop more targeted therapeutics
  • How to practically apply genomic data in precision medicine
  • Utilizing the Cloud for collaborative research
  • Developing secure information systems
  • Ethical considerations in the sharing of genomic data
  • How to transition big data into the clinic
  • How to access open source technologies in LS research
  • How to apply big data analytics to mine information

Click here for more information, including how to register.

NPRM Symposium: “I prefer to be asked”

Part Five of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The preamble to the NPRM justifies requiring consent for data and specimen research by contending  that studies indicate that people want to be asked for permission.  However, the literature on this topic is relatively thin.  Available evidence suggests that many people, upon being informed that their heath data and tissues could or would be used in research without their consent (and nothing further is said to prompt the idea that research might delve into controversial matters) are generally fine with such use.  But when also queried whether they would prefer to have been asked, people say they would.  What the literature does not show is that people say: “I object to any use without my consent,” let alone “and I choose that over all the advantages of minimal risk research involving analysis by a computer of digitized files not humanly readable limited to disease-gene associations of thousands of medical records where consent would not be possible but the results will be essential or important to my health, the health of others, and the national health.”  Pluralistic discussion of tradeoffs over time, or an extended, candid national dialogue about the reasons for the present rules, were not in the mix.   Yet still, people said the opposite of “This must not occur without my consent!”

We have already seen one way in which the claim to be respecting the preference to be asked is untrue – it applies to only some research by some organizations.   Now here is another. The commentaries to the NPRM celebrate as fact that a patient need be asked only once, for all time, and then the only acceptable “yes” answer grants permission for any research by anybody.    It seems doubtful that a one-time consent to any future scientific research by any researcher for any purpose, without ever going back to inform or re-query,  without any regulatory provisions ensuring it was revocable, was what  participants meant by  “being asked.” Rationally, that option is far worse than no consent, for reasons we shall come to. Continue reading

New Food Law and Policy Clinic at UCLA Seeks Clinical Director

CEN_RES_MAIN_produce-7The UCLA Resnick Program is launching a Food Law and Policy Clinic during the 2016-17 academic year.  The clinic’s programmatic mission will be to facilitate sufficient access to socially, economically, and environmentally sustainable food and to improve food environments particularly for low income populations and marginalized communities.

To launch the clinic, we are seeking a Clinical Director who will be expected to teach, develop, and manage the clinic.  The Clinic Director will also work with faculty and administrators to develop and implement other food law and policy related experiential opportunities for students.  The job announcement and details can be accessed at https://recruit.apo.ucla.edu/apply/JPF02172.  Details about our program can be found at: http://www.law.ucla.edu/centers/social-policy/resnick-program-for-food-law-and-policy/

Christina Ho on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we interviewed Christina S. Ho, Associate Professor of Law at Rutgers University. Christina worked on the Domestic Policy Council at the White House and later led Senator Hillary Rodham Clinton’s health legislative staff.

In our lightning round, we discussed an important new study on medical errors as a leading cause of death in the United States. We also addressed the news of Google’s access to health data in Britain, and ongoing controversies at HSCIC (now rebranded NHS Digital).

We asked Christina about her cutting edge work on the Chinese health care system, the right to health care, and comparative health law generally.While China only spends about 5.5% of GDP on health care, almost 50% of the spending is on pharmaceuticals. Christina offers an insightful look at the past, present, and likely near future of Chinese health reforms.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

NPRM Symposium: Quick Take on New Analysis of the Comments on the NPRM to Amend the Common Rule (and the Challenge for Bioethics and the Public)

The Council on Governmental Relations (COGR), with support from the Association of Public and Land-grant Universities (APLU), undertook “to review and analyze the 2,186 public comments submitted in response to the 2015 Federal Policy for the Protection of Human Subjects” or “Common Rule” Notice of Proposed Rulemaking (NPRM).

I am going to discuss some highlights of their just released report, but this is far from exhaustive and you should read the whole report.

For the non-cognoscenti this is the most important revision to the rules for U.S. human subjects research since their inception. The report is largely unfavorable to several key proposed rule changes on my first read, but you should read it yourself to make up your own mind.

I’ll share some choice passages from the analysis

The results of our review (Table 2) find significant opposition to most major proposals, with mixed support for mandated use of a single IRB and extending the Common Rule and greater support for the concept of standard security safeguards. In addition, a number of responses suggested that the NPRM is overly complex, poorly written, and not supported by data; highlighted areas that could have a substantial impact on a final rule but were not included in the NPRM (e.g., proposed security safeguards, a consent template, a list of minimal risk studies and a decision tool); and suggested that some of the proposals would adversely affect human health with little perceived benefit.

Turning to Biospecimens, where we had a conference last year that will soon generate a book with MIT press:

The majority of responses, approximately 1,520, addressed one or more of the proposed changes detailed above involving non-identified biospecimens. Of these responses, 94 – 100% of patients and members of the research community, including researchers, universities, medical centers and industry, opposed the changes. Those commenting suggested that the proposed changes will significantly reduce the availability of biospecimens for research, will have a significant negative impact on medical advances, and will adversely affect human health. Per one patient, “I am asking for life saving policy not life ending policies.” From a biorepository, “Respecting autonomy at the expense of patient lives is a significant ethical concern.”

More surprising was their finding that “Among members of the general public, 55% opposed and 45% supported one or more of the major proposed changes related to biospecimens.” (They do a better breakdown of the various sub-constituencies in the report).

Turning to “broad consent” for biospecimen use:

Continue reading

Divided Infringement in Patent Law and the Doctor-Patient Relationship

By Rachel Sachs

Regular readers of this blog (hi, Mom) will recall that I often think and write about the interaction between the divided infringement doctrine in patent law and medical method patents of various kinds.  In previous posts, I’ve written about the Federal Circuit’s efforts to assign liability for divided infringement of method patents and considered the potential impact on medical method patents (here and here) and I’ve more recently examined a district court opinion applying the Federal Circuit’s analysis to a method-of-treatment claim (here).

I’ve just posted a new essay on SSRN (here, forthcoming in IP Theory) specifically considering the role of the doctor-patient relationship in the Federal Circuit’s analysis.  Would the Federal Circuit see the doctor-patient relationship as fitting within the scope of its divided infringement analysis?  Should it?  These questions are timely, as the Federal Circuit is due to take up these issues very soon.  Briefing before the court in the Eli Lilly case I considered in my last blog post has just been completed, and the case will likely be scheduled for argument later this summer.

Continue reading

NPRM Symposium: So many left behind…

Part Four of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The development of research benefits depends on research participation.  Research participation, in turn, depends on being asked to participate, and how people evaluate what is being asked of them.  This post focuses on a few, not all, of those disproportionately excluded from research through one mechanism or another.  It illustrates some of what the proposed amendments to the Common Rule governing human subjects research will likely mean in practice absent some special vector that changes the outcome.  We will discuss what such a social vector might look like at the end.

We will start with those people who, understanding the real impact and meaning of providing their “blanket consent” to research, and uncomfortable with the sweeping right to invade and permit others to invade their privacy, refuse to sign it.   Who are they? Continue reading

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of April. The selections feature topics ranging from the FDA’s plan to help tackle prescription opioid misuse, to physicians’ knowledge about FDA drug approval standards and breakthrough therapy designation, to a proposal to delink antibiotic reimbursement from sales “using a graded array of benchmarked rewards.” A full posting of abstracts/summaries of these articles may be found on our website.

  1. Califf RM, Woodcock J, Ostroff S. A Proactive Response to Prescription Opioid Abuse. N Engl J Med. 2016 Apr 14;374(15):1480-5.
  2. Goldacre B, Gray J. OpenTrials: towards a collaborative open database of all available information on all clinical trials. 2016 Apr 8;17(1):164.
  3. Kesselheim AS, Woloshin S, Eddings W, Franklin JM, Ross KM, Schwartz LM. Physicians’ Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation. 2016 Apr 12;315(14):1516-8.
  4. Rex JH, Outterson K. Antibiotic reimbursement in a model delinked from sales: a benchmark-based worldwide approach. Lancet Infect Dis. 2016 Apr;16(4):500-5.
  5. Woloshin S, Schwartz LM. US Food and Drug Administration Approval of Flibanserin: Even the Score Does Not Add Up. JAMA Intern Med. 2016 Apr 1;176(4):439-42.

NRPM Symposium: “We are holding health care for ransom, just get naked already!” or “Consent neutrality is non-neutral in effect”

Part Three of Seven-Part Blog Series by Guest Blogger Patrick Taylor

In the previous post of this series, we took a look at how comprehensively certain proposed revisions to human subject research regulations would apply and whether they would, if effective, really fulfill a broad goal of enabling the consent of everyone to researchers’ use of their clinical data.  The answer is a big “No,” based on their scope.  If public trust in science depends, as the government claims, on individuals’ consent reliably and consistently governing research use of their data, then science is in trouble; all the government has proposed is a restriction on the institutions a supermajority of the people trust already to protect their privacy: healthcare providers, researchers funded by the NIH, and a handful of other federal agencies.   Everyone else, from Google to spymaster, drug company to next-door neighbor, is unaffected except to the extent that those entities, or reviewing IRBs, require contracts that say something more, which in this case is left to chance.

The proposed regulations call for government to draft a general blanket consent to govern tissue banking and banked data.  “Blanket” means that it covers everything, in undifferentiated language, with no opt outs – all or nothing.   Such an approach will eliminate most or any choice about what one is consenting to.  It will require consent to any research by anybody using any technique, with any goal in mind.  The options will be to consent to that or not consent at all. Continue reading

Separating sheep from goats- a European view on the patent eligibility of biomedical diagnostic methods

By Timo Minssen

New publication on the patentability of biomedical diagnostics out:

Abstract: This brief comment complements Dan Burk’s excellent paper ( Dolly and Alice, J Law and the Biosciences (2015), 1–21, doi:10.1093/jlb/lsv042 ) by providing a very brief summary of the European approach regarding patents on medical diagnostic methods. This serves as the basis for a comparative discussion of the current US approach and its’ impact on biomedical innovation. We are concerned that unless the Supreme Court clarifies its two-part test and adopts a more holistic interpretation of the eligibility-test, global standards for medical diagnostic patents will diverge to the detriment of advanced therapies and ultimately patients worldwide. In case that the current US eligibility doctrine prevails without further Supreme Court clarification, we highlight the need for developing a more flexible, well-calibrated system for alternative and complementary forms of drug development incentives. In addition to a better-funded and well-administered prize system (an interesting option for some areas of diagnostics that we did not elaborate upon), our paper highlights the need for an improved and more flexible system for regulatory exclusivities in this sector.

Citation: Separating sheep from goats: a European view on the patent eligibility of biomedical diagnostic methods Timo Minssen; Robert M. Schwartz Journal of Law and the Biosciences 2016; doi: 10.1093/jlb/lsw019

 

 

 

 

Prior Authorization Policies for Pediatric ADHD Medication Prescriptions

According to the Centers for Disease Control and Prevention, more than 6.4 million US children 4-17 years old have been diagnosed with attention-deficit/hyperactivity disorder (ADHD). The percentage of US children diagnosed with ADHD has increased by 3-5 percent per year since the 1990s. Relatedly, the percentage of children in this age group taking ADHD medication also has increased by about 7 percent per year from 2007-2008 to 2011-2012.

In response, some state Medicaid programs have implemented policies to manage the use of ADHD medications and guide physicians toward best practices for ADHD treatment in children. These policies include prescription medication prior authorization requirements that restrict approvals to patients above a certain age, or require additional provider involvement before approval for payment is granted.

In a new article published this afternoon in MMWR, CDC researchers compared Medicaid and employer-sponsored insurance (ESI) claims for “psychological services” (the procedure code category that includes behavior therapy) and ADHD medication among children aged 2–5 years receiving clinical care for ADHD.

The article references a newly released LawAtlas map that examines features of state Medicaid prior authorization policies that pertain to pediatric ADHD medication treatment, including applicable ages, medication types, and criteria for approval.

States with Medicaid programs that have a policy that requires prior authorization for ADHD medications prescribed to children younger than 28 years old.

States with Medicaid programs that have a policy that requires prior authorization for ADHD medications prescribed to children younger than 28 years old.

Continue reading

NPRM Symposium: Privacy and Promises, Promises, Promises

Part Two of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The first blog post in this series probably provided a few surprises, but the surprises are just beginning. Can the NPRM to amend the Common Rule keep its promises?

The NPRM promises that patients will be able to consent to use of their clinical data in research, which is actually two promises, not one. The first is that the consent will be given effect. The second is that the refusal will be given effect.  As to refusal, the NPRM absolutely does not keep its promise.

The NPRM is filled with page after page of exceptions where your consent is not required. These include examples like trailing you and spying on you in public, some tests done on how to affect children’s behavior, and more. Continue reading